Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

October 14, 2019

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Urothelial Cancer
Interventions
DRUG

Niraparib plus Cabozantinib

Non-randomized trial will comprise 2 stages. A dose escalation phase will characterize the safety, tolerability, DLTs and MTD, of oral niraparib plus cabozantinib in patients with urothelial or renal cell carcinoma. Subsequently, the phase II will further evaluate the safety and antitumor activity of this combination in patients with urothelial carcinoma.

Trial Locations (10)

Unknown

Xarxa Assistencial Universitària de Manresa, Barcelona

ICO Badalona, Badalona

Hospital Clinic, Barcelona

ICO Girona, Girona

ICO L'Hospitalet, L'Hospitalet de Llobregat

Hospital 12 de Octubre, Madrid

Hospital Madrid Norte Sanchinarro, Madrid

Hospital Ramon y Cajal, Madrid

Hospital Marques de Valdecilla, Santander

Instituto Valenciano de Oncología, Valencia

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Apices Soluciones S.L.

INDUSTRY

lead

Fundacion CRIS de Investigación para Vencer el Cáncer

OTHER